Supreme Court prescribes pain relief for 15 banned combination drugs

The order effectively brings several popular cough syrups, painkillers and cold medication out of the health ministry’s impending ban list, providing relief to drug companies pegged at over Rs 740 crore annually.

The Supreme Court told the government it could not use a technical advisory body’s report to prohibit 15 types of combination medicines manufactured in India since before 1988, said lawyers present during the proceedings, providing relief to several pharmaceutical companies including Abbott, Cipla and Intas.

The order effectively brings several popular cough syrups, painkillers and cold medication out of the health ministry’s impending ban list, providing relief to drug companies pegged at over Rs 740 crore annually.

The court has said that the government can still look into the safety of these 15 drugs, known as fixed-dose combinations (FDCs), but would have to initiate a fresh investigation in case it wants to ban them, said lawyers.

The court was hearing a case filed by Griffon Laboratories, which had challenged a decision by the Drugs Technical Advisory Board (DTAB) subcommittee to study these 15 FDCs despite previous orders by the apex court that had said these combinations were not to be considered by the panel. Griffon makes cough syrup Grilinctus, which is now out of the ban list following the developments on Friday, said Anupam Lal Das, the Supreme Court advocate-on-record who had filed the case on behalf of Griffin.

Supreme Court prescribes pain relief for 15 banned combination drugs

“The SC had specifically quashed the ban notifications with regard to these 15 FDCs in its earlier judgment (December 2017),” Das said.

“Our contention was that the subcommittee was still looking into these drugs in violation of the court’s order.” FDCs are medicines with two or more therapeutic ingredients packed in a single dose. They are available in various forms such as tablets and syrups.

Companies such as Abbott will benefit greatly from the order as brands like Phensedyl contributed about Rs 340 crore to revenue between August 2017 and July 2018, according to pharmaceutical market research firm AIOCD PharmaTrac.

In December, the apex court had asked DTAB to recommend to the health ministry the FDCs that needed to be regulated, restricted or banned outright along with the reasons for doing so. This followed an extended legal battle between the government and drug companies over the health ministry’s decision to ban nearly 350 FDCs in 2016 and 2017 deeming them “unsafe” and “irrational” for patient use.

RS 3,000-CR SALES HIT

PharmaTrac estimated the move would shave off over Rs 3,000 crore from the annual Rs 1 lakh crore revenue of India’s pharmaceutical industry back then and hundreds of drug companies had approached high courts across the country against the decision.

The latest development comes even as the health ministry is considering a report submitted by the DTAB sub-committee to ban over 300 FDCs, including the 15 that were contested at court. The subcommittee had recommended even these FDCs be banned along with 328 others because there is not enough evidence to support assertions that they are safe.

A bench of RF Nariman and Indu Malhotra held that the subcommittee could not look into these 15 FDCs due to its earlier judgement, according to Archana Sahadeva, associate partner at Singh & Singh Law Firm, who was present at the proceedings.

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